Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: This position is an integral part of the program assuring that raw materials used in manufacturing can be consistently supplied and are of the appropriate quality to ensure the production of drug products meeting or exceeding expectations while maintaining compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Participate in and perform raw material activities according to approved procedures including but not limited to the qualification of raw materials, evaluation of TSE/BSE statements from Suppliers, evaluation of Supplier Change for raw materials to support investigations, etc.
Education and Experience:
* Performs continuous improvement of the QA Raw Material program using a variety of methodologies (QRM, Lean, etc.)
* Supports and/ or leads the resolution of deviations (NOEs and DNFs) and change controls related to raw materials.
* Gather, evaluate and provide information/documentation to support regulatory filings, regulatory agency inspections and inquiries, as well as partner and internal audits.
* Analyze the raw material testing results and determine the acceptability of results in accordance with the approved Specifications.
* Represent QA and interact with various functional areas in meetings pertaining to raw material issues including but not limited to Material Review Board, Material Council Board, 2S, Supplier Change Notification, Supplier Relationship Meetings, etc.
* Manage and track projects to ensure milestones are achieved while complying with established timelines.
* Participate in Vendor Development Program designed to create a transparent and quality focused partnership with Suppliers.
* Visit/Interact with Suppliers to gain intimate knowledge of their manufacturing process and quality systems.
* Work with Suppliers to reduce quality issues/complaints, communicate Regeneron's expectations, and strengthen partnership with key Suppliers
*Hours for this position may include weekend and/or evening hours*
* Requires a BS degree in a Scientific discipline and minimum 3+ years of related experience.
* Experience with supplier management and resolution of issues is preferred.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.